Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Bayer

Status and phase

Terminated

Phase 2

Conditions

Small Cell Lung Carcinoma

Treatments

Drug: Sagopilone (BAY86-5302, ZK 219477)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00299390

307972

91375

2005-000597-53 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically proven Small-cell lung cancer (SCLC)
Stage of extensive disease defined by the presence of distant metastases
At least 1 unidimensionally measureable lesion
WHO performance status 0 to 1
No previous SCLC-related chemotherapy
No previous SCLC-related surgery
No previous radiotherapy (excepting for brain metastasis)
Adequate function of major organs and systems
- Nervous system
  - No Grade 2 or greater peripheral neuropathy
- Cardiovascular:
  - No symptomatic congestive heart failure
  - No unstable angina pectoris
  - No arrythmia needing continuous treatment
  - No other uncontrolled concurrent illness

Exclusion criteria

Superior vena cava syndrome or obstruction of any vital structure
Untreated malignant hypercalcemia
Pleural effusion as the only manifestation of disease
Extensive disease amenable to radiation therapy
Symptomatic brain metastases requiring whole brain irradiation
Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix